An object of the present invention is to provide apparatus and a method for performing corrective surgery on internal wounds such as hernia where invasion of the patient's body tissues is minimized and resultant trauma is reduced.
A hernia is a protrusion of a tissue, structure, or part of an organ through the muscular tissue or the membrane by which it is normally contained. In other words a hernia is a defect in the abdominal wall through which a portion of the intra-abdominal contents can protrude. This often causes discomfort and an unsightly, visible bulge in the abdomen. When such a hernia defect occurs in the abdominal region, conventional corrective surgery has required opening the abdominal cavity by surgical incision through the major abdominal muscles. While this technique provides for effective corrective surgery of the hernia defect, it has the disadvantage of requiring a hospital stay of as much as a week, during which pain is frequently intense, and it requires an extended period of recuperation. After the conventional surgery patients frequently cannot return to a full range of activity and work schedule for a month or more. Accordingly, medical science has sought alternative techniques that are less traumatic to the patient and provide for more rapid recovery.
Laparoscopy is the science of introducing a viewing instrument through a port into a patient's body, typically the abdominal cavity, to view its contents. This technique has been used for diagnostic purposes for more than 75 years. Operative laparoscopy is performed through tiny openings in the abdominal wall called ports. In most surgical techniques several ports, frequently three to six, are used. Through one port is inserted the viewing device, which conventionally comprises a fiber optic rod or bundle having a video camera affixed to the outer end to receive and display images from inside the body. The various surgical instruments are inserted through other ports to do the surgery that normally would be performed through an open incision through the abdominal wall. Because the laparoscopic surgical techniques require only very small holes through the abdominal wall or other portions of the body, a patient undergoing such surgery may frequently leave the hospital within one day after the surgery and resume a full range of normal activities within a few days thereafter.
In repairing hernia the physician needs to first deploy the patch and then to attach the patch to the tissue.
There are many patents and patent applications relating to attaching a prosthesis implant to a tissue via tacks. Each patent and patent application describes a different attachment mechanism via different anchoring means (see for example U.S. Pat. No. 6,447,524). Traditional anchors used in surgery include clips, staples, or sutures, and may also be referred to as tissue anchors. These devices are usually made of a biocompatible material (or are coated with a biocompatible material), so that they can be safely implanted into the body. Most tissue anchors secure the tissue by impaling it with one or more posts or legs that are bent or crimped to lock the tissue into position. Thus, most traditional anchors are rigid or are inflexibly attached to the tissue. For example PCT no. WO07/021,834 describes an anchor having two curved legs that cross in a single turning direction to form a loop. Those two curved legs are adapted to penetrate tissue in a curved pathway. U.S. Pat. No. 4,485,816 (refers hereinafter as 816') describes surgical staple made of shape memory alloy. The staple is placed in contact of the tissue and then heated. The heating causes the staple to change its shape thus, penetrating the tissue.
U.S. Pat. No. 6,893,452 (refers hereinafter as '452) describes a tissue attachment device that facilitates wound healing by holding soft tissue together under improved distribution of tension and with minimal disruption of the wound interface and its nutrient supplies. The device has multiple sites for grasping the tissue using tines or prongs or other generally sharp, projecting points, protruding from a single, supportive backing. One of the embodiments described in '452 is the use of sharp projecting points protruding from the supportive backing in two different angles.
U.S. Pat. No. 6,517,584 (refers hereinafter as '584) describes a hernia patch which includes at least one anchoring device made of shape memory material. The anchoring devices are initially secured to the prosthesis by being interlaced through a web mesh constituting the prosthesis. The attachment is obtained by altering the attachment element's shape from rectilinear to a loop shape due to heat induced shape memory effect.
Yet other patent literature relates to devices for endoscopic application of surgical staples adapted to attach surgical mesh to a body tissue.
An example of such a teaching is to be found in U.S. Pat. Nos. 5,364,004, 5,662,662, 5,634,584, 5,560,224, 5,588,581 and in 5,626,587.
There are a few patent and patent applications teaching the deployment of patches. For example U.S. Pat. No. 5,836,961 (refers hereinafter as '961) which relates to an apparatus used for developing an anatomic space for laparoscopic hernia repair and a patch for use therewith. The apparatus of U.S. Pat. No. '961 comprises a tubular introducer member having a bore extending therethrough. A tunneling shaft is slidably mounted in the bore and has proximal and distal extremities including a bullet-shaped tip. A rounded tunneling member is mounted on the distal extremity of the tunneling shaft. The apparatus comprises an inflatable balloon. Means is provided on the balloon for removably securing the balloon to the tunneling shaft. Means is also provided for forming a balloon inflation lumen for inflating the balloon. The balloon is wrapped on the tunneling shaft. A sleeve substantially encloses the balloon and is carried by the tunneling shaft. The sleeve is provided with a weakened region extending longitudinally thereof, permitting the sleeve to be removed whereby the balloon can be unwrapped and inflated so that it lies generally in a plane. The balloon as it is being inflated creates forces generally perpendicular to the plane of the balloon to cause pulling apart of the tissue along a natural plane to provide the anatomic space.
Although U.S. Pat. No. '961 relates to deploying means, U.S. Pat. No. '961 teaches a device in which the patch is attached to a balloon which is introduced into the abdominal cavity. The deployment is performed by inflating the balloon. In other words, a totally different deploying means are disclosed.
Furthermore, due to the relatively large volumes of balloons several disadvantages are likely to occur: (a) The visibility within the abdominal cavity might be damaged; (b) The accessibility of the attachment means to the patch might be impaired; and, (c) The maneuverability of the patch within the abdominal cavity is limited.
Yet more, another major drawback to U.S. Pat. No. '961, the inflated balloon lacks any mechanical stiffness which is needed for navigation of the patch to its position.
Another example for deploying the patch can be found in U.S. Pat. No. 5,370,650 (refers hereinafter as '650) which relates to an apparatus for positioning surgical implants adjacent to body tissue to facilitate the fastening of the implant to the body tissue. U.S. Pat. No. '650 provides an apparatus for positioning surgical implants adjacent to body tissue, comprising an outer tube having a proximal end, a distal end and a longitudinal axis; an inner rod at least partially disposed within the outer tube and slidable along said longitudinal axis. The inner rod has a proximal and a distal end portions. The inner rod distal end portion further comprises articulating means for pivoting at an angle with respect to the longitudinal axis. A looped support member having first and second end portions fixedly secured to said distal end portion of the inner rod; and a surgical implant releasably secured to the looped support member (a preferred embodiment illustrating the teaching of U.S. Pat. No. '650 is illustrated in FIG. 17).
The major difference between U.S. Pat. No. '650 and the present invention is the actual patch deployment mechanism.
While in U.S. Pat. No. '650, the looped support member 14 is transferred from a deployed configuration to a retracted configuration by pushing and pulling tube 12, in the proposed technology the flexible arms are reconfigured from their initial stage (IS) to their final stage (FS) by the reciprocal movement the central shaft. In other words, while in U.S. Pat. No. '650, the patch is deployed due to the elasticity of the loop member (no force is applied), in the present application, the patch is deployed by actively and directly applying force on the Flexible arms by the surgeon.
Furthermore, the deployment of the patch in U.S. Pat. No. '650 is passive and unidirectional; i.e., once the patch is deployed by pulling tube 12, the patch can not be un-deployed and reinserted into tube 12. In order to reinsert the patch into tube 12, the patch must be refolded and such an action can not be performed while the patch is within the patient. Therefore, the surgeon has only one chance to unfold the patch. This is in sharp contrary to the present invention in which the deployment of the patch is bidirectional and actively controlled such that the patch can be deployed and un-deployed simply by the reconfiguration of the flexible arms (which a full description will be provided in the detail description).
Yet another major distinction between U.S. Pat. No. '650 and the proposed invention is the fact that in U.S. Pat. No. '650 the looped support member 14 is preferably in a deployed (i.e., open) configuration thereby insertion of the looped support member 14 into tube 12 will require the physician to apply a significant amount of force in order to maintain the looped support member 14 in a closed configuration. On the contrary, in the present invention, the flexible arms can be actively configured to be constantly closed without any additional force applied by the physician. Therefore, the insertion of the device through a trocar is facilitated.
Yet more, the present invention comprises a central shaft for providing the device mechanical stiffness for the backbone of the system which is needed for better positioning of the patch within the body. Further, by providing mechanical stiffness to the backbone of the system, it will enable the detachment of the patch from the deployment system. Such a mechanism is not disclosed nor claimed in U.S. Pat. No. '650.
Lastly, U.S. Pat. No. '650 describes no attachment mechanism for attaching the patch to the tissue. Further, some major, non obvious modification will have to be made in order to enable attachment between the patch and the tissue whilst using the device of U.S. Pat. No. '650.
More patent literature can be found in PCT no. WO08065653 (refers hereinafter as '653) relates to a device especially adapted to deploy a patch within a body cavity. The device is an elongate open-bored applicator (EOBP) and comprises (a) at least one inflatable contour-balloon, (b) at least one inflatable dissection balloon. The inflatable contour-balloon and the inflatable dissection balloon are adjustable and located at the distal portion. The EOBP additionally comprises (c) at least one actuating means located at the proximal portion. The actuating means is in communication with the inflatable contour-balloon and the inflatable dissection balloon. The actuating means is adapted to provide the inflatable contour-balloon and the inflatable dissection balloon with independent activation and/or de-activation.
It should be pointed out that PCT '653 does not disclose nor claim means adapted to anchor the patch to the biological tissue.
Like U.S. Pat. No. '961, the deployment system describes in PCT '653 is an inflated one, thus it is fundamentally different from the proposed invention.
All those patent and patent application demonstrate attachment means for attaching the patch to the tissue or means for deploying the patch within the body. However none of the literature found relates to a device especially adapted to deploy and attached a patch to a biological tissue.
Thus, there is still a long felt need for a device that can be used for both deploying and attaching a patch to a biological tissue.
Furthermore, there is still a long felt need for a deployment system that will overcome the above mentioned drawbacks and will provide a deployment system that will enable the following (i) a reversible deployment of the patch (i.e., enable the folding and the unfolding of said patch); (ii) a controlled deployment of the patch (i.e., the surgeon applies force in order to deploy the patch and therefore the deployment is actively controlled); and, (iii) will provide mechanical stiffness for the backbone of the system.